Manufacturing QMS Specialist

Global Life Science Hub is excited to collaborate with an innovative biopharmaceutical company leading advancements in cutting-edge drug delivery technologies. Following two recent FDA approvals, they are gearing up for substantial growth. By 2025, they will launch new internal manufacturing facilities that will triple their production capacity as they seek their 3rd approval.

To support the next growth phase, we are seeking a Manufacturing QMS Specialist who will be responsible for writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPA etc. This position requires technical expertise in upstream and downstream process of biologics (Cytokines, monoclonal antibodies manufacturing) 

Responsibilities:

• Responsible to support manufacturing team with all kinds of documentation.
• Documentation includes reviewing executed batch records (both Upstream department and Downstream batch...